Visus Therapeutics Inc. announced it has concluded enrollment and conducted the last visit in its pivotal phase 3 trial BRIO-1 for its lead investigational asset, BRIMOCHOL PF—a once-daily eye drop—to correct the loss of near vision associated with presbyopia.
What is BRIMOCHOL PF?
BRIMOCHOL PF is a topical, preservative-free, and fixed-dose ophthalmic solution consisting of a combination of carbachol and brimonidine tartrate (both FDA-approved).
The formulation creates and sustains a “pinhole effect” by reducing the pupil size to allow only centrally-focused light rays to enter the eye, resulting in enhanced, sustainable vision and clarity for near (i.e. reading, smartphone/tablet use) and intermediate visual tasks (i.e. staring at a computer screen).
How does this combination action work?
Carbachol is a cholinergic agent that is known for its potency and increased duration of activity as a miotic agent—meaning it reduces the size of the pupil, leading to near visual acuity (VA) improvement—via pupil constriction.
Briminodine tartrate is a highly selective alpha-2 agonist that prevents ciliary muscle contraction by way of alpha-2 receptor activation. Thus, this sympatholytic agent can potentially mitigate miotic side effects.
Now talk about the phase 3 study.
According to Visus, the double-masked, randomized, multi-center, safety and efficacy study (NCT05135286) is enrolling 450 patients (ages 45-80) diagnosed with emmetropic phakic and pseudophakic presbyopia.
Participants will receive either a combined single drop of BRIMOCHOL PF, a single drop of Carbachol PF, or a single drop of vehicle at each visit.
The primary outcome measurement is the percentage of patients with 3-line improvement in near VA without the loss of 1 line in distance VA.
When can we expect results?
Visus expects to have a data readout by Q2 2023 (the study’s Clinical Trials page estimates May 31, 2023, for study completion).
Significance?
According to Rhett Schiffman, MD, MS, MHSA, Visus co-founder, chief medical officer and head of research and development, the company has the potential to “become the first company to meet this FDA-required high bar for approving a combination product for presbyopia in a pivotal phase 3 study.”